Method and Apparatus for Minimally Invasive Subcutaneous Treatment of Long Bone Fractures

ABSTRACT

The instant invention is a novel method and construct for temporary or definitive minimally invasive treatment of broken long bones such as a femur or humerus. The method includes the steps of tunneling an elongated rod subcutaneously in the subcutaneous fat layer parallel to the fractured long bone; and attaching the ends of the elongated rod to the fractured long bone. The elongated rod remains disposed in the subcutaneous fat layer and away from, but parallel to the long bone once attached to the long bone.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of and claims the priority ofU.S. application Ser. No. 13/846,330 filed Mar. 18, 2013, which is acontinuation of U.S. application Ser. No. 12/592,476 filed Nov. 27,2009, now U.S. Pat. No. 8,398,686.

FIELD OF THE INVENTION

The present invention relates to methods of temporary and/or permanentfixation of long bone fracture. More specifically the invention relatesto minimally invasive subcutaneous treatment of fractures of the femurand humerus. Most specifically the instant invention offers a treatmentmethod and device that is useful for minimally invasive internalfixation of the fractured long bone with no external components andtherefore reduced chance for infection. This method and device arehighly suitable for battlefield injuries, use in children, and use inthird world countries where more extensive treatment may not beavailable.

BACKGROUND OF THE INVENTION

There are presently two basic techniques for safe transportation of awounded soldier with a long bone fracture: 1) transportation casts and2) temporary external fixation. Both of these methods are presentlyaccepted for initial treatment of a patient who will be evacuated out oftheater. Precise indications for external fixator use versus castinghave not been established.

In general, good indications for external fixator use include when thesoft tissues need to be evaluated while en route, such as with avascular injury; when other injuries make use of casting impractical,such as with a femur fracture and abdominal injury; or when the patientshave extensive burns. Advantages of external fixation are that it allowsfor soft tissue access, can be used for polytrauma patients, and has aminimal physiologic impact on the patient. Disadvantages are thepotential for pin site sepsis or colonization and less soft tissuesupport than casts.

Advantages of transportation casts are that they preserve the maximumnumber of options for the receiving surgeon; the soft tissues are wellsupported, and the casts are relatively low tech. Disadvantages are thatcasts cover soft tissues, may not be suitable for polytrauma patients,and are more labor-intensive than external fixators.

Though standard in civilian trauma centers, intramedullary nailing ofmajor long bone fractures is contraindicated in combat zone hospitalsbecause of a variety of logistical and physiologic constraints. Thismethod may be used once a patient reaches an echelon above corps (EAC)or other site where more definitive care can be provided.

Therefore, although both transportation casts and external fixators areequally acceptable methods for the initial management of long bonefractures, each has its disadvantages. Additionally, current methods ofinternal fixation are contraindicated, especially considering theextensive length and depth of incision required to place the fixationplate adjacent to the fractured bone. Thus, there is a need in the artfor a method and apparatus for the safe transportation of a woundedsoldier with a long bone fracture which allows for access to the softtissues as needed, and yet reduces the chances of infection, sepsis orcolonization.

SUMMARY OF THE INVENTION

The present invention comprises a surgical method and device forminimally invasive treatment of long bone fractures. The methodcomprises the steps of: tunneling an elongated rod subcutaneously in thesubcutaneous fat layer parallel to the fractured long bone; andattaching the ends of the elongated rod to the fractured long bone usingattachment means. The elongated rod and the attachment means remaindisposed in the subcutaneous fat layer and away from, but parallel tothe long bone once attached to the long bone.

The tunneling step may include creating one or more incisions in theskin through which the elongated rod can be inserted. The long bone maybe a femur and the one or more incisions in the skin may be created onthe lateral anterior part of the thigh. The step of attaching the endsof the elongated rod to the fractured long bone may include connectingthe attachment means to attachment clamps, the clamps being attached tothe elongated rod, and inserting the attachment means into the bone. Theattachment clamps may include means to clamp the attachment means andthe elongated rod to one another in a generally perpendicularrelationship.

The attachment clamps may include a body having two passagewaystherethrough, the passageways being generally perpendicular to oneanother, the passageways allowing for passage of the attachment meansand the elongated rod therethrough. The attachment clamps may furtherinclude two set screw passageways therein to accommodate two set screwswhich lock the elongated rod and the attachment means firmly into theattachment clamp.

The step of attaching the ends of the elongated rod to the fracturedlong bone may further include the step of inserting a threaded rod intoa first end of the long bone the threaded rod being used to hold thefirst end steady before the step of inserting attachment screwsthereinto and to the attachment clamps. The step of attaching the endsof the elongated rod to the fractured long bone may further include thesteps of 1) inserting an end of the elongated rod through a firstpassageway in one or more of the attachment clamps; 2) inserting theattachment means through a second passageways in the attachment claps,and into the proximal end of the long bone; 3) fixing the elongated rodand the attachment means into the attachment clamps using set screws.

The step of attaching the ends of the elongated rod to the fracturedlong bone may further include the step of distracting and aligning thefractured long bone. The step of distracting and aligning the fracturedlong bone may include inserting a threaded rod into the distal end ofthe long bone and manually distracting and aligning the fractured longbone. The step of distracting and aligning the fractured long bone mayinclude inserting an attachment means and attachment clamp to the distalend of the elongated rod and into the distal end of the long bone andusing the attachment means and attachment clamp to manually distract andalign the fractured long bone.

The step of attaching the ends of the elongated rod to the fracturedlong bone may further include the step removing the portion of theattachment means which extends away from the long bone beyond theattachment clamp to prevent the attachment means from extending beyondthe subcutaneous fat layer.

The surgical device for minimally invasive fixation of long bonefractures may including: an elongated rod, the rod being of sufficientlength to extend substantially between the proximal and distal ends ofthe fractured long bone and being designed to be placed within thesubcutaneous fat layer; a plurality of attachment means designed toattach the elongate rod to the proximal and distal ends of the fracturedlong bone; and a plurality of attachment clamps, each designed toconnect the attachment means to the elongated rod in a generallyperpendicular fashion.

The attachment clamps may include a body having two passagewaystherethrough, the passageways being generally perpendicular to oneanother, the passageways allowing for passage of the attachment meansand the elongated rod therethrough. The attachment clamps may furtherinclude two set screw passageways therein to accommodate two set screwswhich lock the elongated rod and the attachment means firmly into theattachment clamp. The attachment means may be a screw, threaded pin orthreaded rod. The attachment means may be a Schanz pin. The attachmentmeans may have a shaft portion and the shaft portion may be threadedonly on the portion thereof that is inserted into the long bone. Theattachment means might not extend outward from the long bone beyond theattachment clamp.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a depiction of a thigh having a broken femur;

FIG. 2 depicts a prior art external fixation technique showing how themechanisms of the external fixator are attached by pins to the brokenportions of the femur;

FIG. 3 is a schematic depiction of the manner in which the elongated rodmay be placed subcutaneously in the thigh;

FIG. 4 is a schematic depiction of an alternative view of the manner inwhich the elongated rod is tunneled subcutaneously inside the thighparallel to the broken femur between two incisions;

FIG. 5, depicts how a threaded rod 9 may be placed into one end of thebone after the rod has been placed into the thigh;

FIG. 6 shows attachment means which may be used in the inventive methodand with the inventive device;

FIG. 7 depicts the manner in which attachment means 10, attachmentclamps 7 and rod 6 are attached through the incision into the bone 2;

FIG. 8 depicts the results of insertion of three attachment means 10into one part of the fractured bone 2 and an additional attachment means10 into the other part of the bone 3, the additional attachment meansbeing useful to align and distract the bone;

FIG. 9 shows the rod 6 attached to both ends of the bone via attachmentmeans 10, and clamps 6

FIG. 10 depicts how the excess ends of the attachment means 10 may beremoved to allow the entire fixation construct to be placedsubcutaneously; and

FIG. 11 is a depiction of a cross-section of a thigh 1 having theelongated rod 6 of the present invention disposed in the subcutaneousfat layer 22, the rod 6 being held to bone 2,3 using attachment means10, which is attached to the elongated rod 6 using attachment clamp 7.

DETAILED DESCRIPTION OF THE INVENTION

The instant invention is a novel method and construct for temporary ordefinitive minimally invasive treatment of broken long bones such as afemur or humerus. FIG. 1 is a depiction of a thigh 1, having a femurwhich is broken into two pieces 2 and 3. One aspect of the presentinvention is an internal fixator for the femur or humerus which sitssubcutaneously. The fixator is a rod and clamp system which is insertedunder the skin above the fascia in the subcutaneous space. Its advantageis for transport of military wounded from the field to the definitivecare facility. As noted above, currently patients/soldiers aretransferred with an external fixator which has pins screwed into thebone connected to bars outside of the skin. FIG. 2 depicts this priorart fixation technique showing how the mechanisms 4 of the externalfixator are attached by pins to the broken portions of the femur 2, 3via holes in the skin 5. The external fixators are cumbersome and canlead to infection. The external fixators need to be replaced by rods orplates at the definitive care facility. If an external fixator is usedon a patient for longer than 7 to 10 days there is a risk for pin siteinfection if it is later decided to nail the femur or humerus. Alsobecause the pins extend from the bone to outside the skin there isalways a risk for pin site infection.

With the inventive device and method, definitive surgery can beperformed without the risk of infection as the device is under the skin.The device is easy to apply and, because the hardware is totallysubcutaneous, it is not unwieldy for the patient or for the transportingteam. Medical personnel can safely wait until the soldier is safe forfurther surgery without the risk of infection.

While the inventive device and method can be used for battlefield traumaof long bones, the treatment can also be used for children between 3 to12 years of age. The inventive internal fixator can be definitivetreatment but should be removed after 8 weeks to 3 months. In thiscontext, the present invention would replace the use of flexible endernails. The inventive device is much stiffer than flexible ender nailsand would not need any other immobilization.

Further, in civilian treatment the present method and device may be usedto temporize polytrauma patients as a damage control measure and maylater be replaced by conventional internal fixation. The present methodand device may be used as definitive care in certain situations whenfurther surgery is not possible. The present method and device would beexceptionally useful in peripheral centers when used to transferpatients after early treatment to a definitive care facility.

Also the inventor notes that the present method and device could be usedas definitive fixation in third-world areas where a C-arm is notavailable as it is easy to apply. Of course, it would still need to beremoved after 3 months in adults.

Turning now to a detailed description of the present method and device,FIG. 3 is a schematic depiction of the manner in which the elongated rod6 may be placed subcutaneously in the thigh 1. The rod 6 may be placedinto the subcutaneous fat layer through two incisions 8 in the skin. Oneincision is near the proximal end of the bone and one is near the distalend of the bone. The incisions 8 may be approximately 2 inches or lesson each end and may preferably be placed in the lateral anterior area ofthe thigh 1 when the bone being fixated 2,3 is a femur. Of course, therod 6 may come in many different sizes to accommodate different bonesizes. This placement of the elongated rod 6 just under the skinprevents disruption of the muscle tissue and since there is nodissection, there is little chance for infection. FIG. 4 is a schematicdepiction of an alternative view of the manner in which the elongatedrod 6 is tunneled subcutaneously inside the thigh 1 parallel to thebroken femur 2,3 between the two incisions 8.

As shown in FIG. 7, once the rod 6 has been placed into the thigh, athreaded rod 9 may be placed into one end of the bone 2. Preferably therod 9 is placed into the proximal end of the bone. This threaded rod maybe used to hold the bone in place as the rod 6 is attached to the bone.

FIG. 6 shows attachment means which may be used in the inventive methodand device. Threaded rods 9 may be used to hold the broken bone sectionssteady as screws 10 are used to attach the device to the bone.Attachment screw 10 may have a threaded shaft 12, preferably threadedonly on the end thereof that will be inserted into the bone. Attachmentscrews 10 may be cortical screws, such as uni-cortical or bi-corticalscrews, Schanz pins, or other threaded rod type devices. The attachmentmeans 10 are attached to the elongated rod by attachment clamps 7. Theclamps 7 allow the attachment means 10 and the elongated rod 6 to beattached to each other in a generally perpendicular fashion. An exampleof such an attachment clamp 7 is depicted in FIG. 6. The attachmentclamp has two perpendicular passageways (11 a and 11 b) therein throughwhich elongated rod 6 and attachment means 10 separately pass. Theattachment clamp 7 also has two set screw passageways (11 a′ and 11 b′)to accommodate set screws which lock the elongated rod 6 and attachmentmeans 10 firmly into the attachment clamp.

Next, as shown in FIG. 7, attachment means 10 are inserted through theattachment clamp 7, which is attached to the elongated rod 6 and intothe bone 2. Preferably each end of the elongate rod is attached to thebone by three or more sets of attachments 10 and attachment clamps 7.FIG. 7 depicts the results of placement of three attachment screws 10and three attachment clamps 7.

FIG. 8 depicts the manner in which the attachment means 10 may beinserted into the other end of the bone 3 and attached to elongated rod6 via attachment clamp 7. The attachment means 10 and clamp 7 may beused to align and distract the bone 3, or at a minimum, hold it in placeas additional attachment means 10 are inserted into the bone 3.

FIG. 9 depicts three sets of attachment means 10 and attachment clamps 7attached to the other (proximal) end of the bone 3, which align andfixate the bone to allow for healing/regrowth thereof.

FIG. 10 shows how the excess ends of the attachment means 10 may beremoved to allow the entire fixation construct to be placedsubcutaneously.

Finally, FIG. 11 is a depiction of a cross-section of a thigh 1 havingthe elongated rod 6 of the present invention disposed in thesubcutaneous fat layer 22. The rod 6 is held to bone 2,3 usingattachment means 10, which is attached to the elongated rod 6 usingattachment clamp 7.

It is to be expected that considerable variations may be made in theembodiments disclosed herein without departing from the spirit and scopeof this invention. Accordingly, the significant improvements offered bythis invention are to be limited only by the scope of the followingclaims.

I claim:
 1. A surgical method for minimally invasive treatment of longbone fractures comprising the steps of: tunneling an elongated rodsubcutaneously in the subcutaneous fat layer parallel to the fracturedlong bone; and attaching the ends of the elongated rod to the fracturedlong bone using attachment means; wherein said elongated rod and saidattachment means remain disposed in the subcutaneous fat layer and awayfrom, but parallel to the long bone once attached to the long bone. 2.The surgical method of claim 1, wherein said tunneling step includescreating one or more incisions in the skin through which said elongatedrod can be inserted.
 3. The surgical method of claim 2, wherein saidlong bone is a femur and said one or more incisions in the skin arecreated on the lateral anterior part of the thigh.
 4. The surgicalmethod of claim 1, wherein said step of attaching the ends of saidelongated rod to said fractured long bone includes connecting saidattachment means to attachment clamps, which clamps are attached to saidelongated rod, and inserting said attachment means into said bone. 5.The surgical method of claim 4, wherein said attachment clamps includemeans to clamp said attachment means and said elongated rod to oneanother in a generally perpendicular relationship.
 6. The surgicalmethod of claim 5, wherein said attachment clamps include a body havingtwo passageways therethrough, said passageways being generallyperpendicular to one another, said passageways allowing for passage ofsaid attachment means and said elongated rod therethrough.
 7. Thesurgical method of claim 6, wherein said attachment clamps furtherinclude two set screw passageways therein to accommodate two set screwswhich lock said elongated rod and said attachment means firmly into saidattachment clamp.
 8. The surgical method of claim 7, wherein said stepof attaching the ends of said elongated rod to said fractured long bonefurther includes the step of inserting a threaded rod into a first endof said long bone said threaded rod being used to hold said first endsteady before the step of inserting attachment screws thereinto and tosaid attachment clamps.
 9. The surgical method of claim 8, wherein saidstep of attaching the ends of said elongated rod to said fractured longbone further includes the steps of 1) inserting an end of said elongatedrod through a first passageway in one or more of said attachment clamps;2) inserting said attachment means through a second passageways in saidattachment claps, and into the proximal end of said long bone; 3) fixingsaid elongated rod and said attachment means into said attachment clampsusing set screws.
 10. The surgical method of claim 9, wherein said stepof attaching the ends of said elongated rod to said fractured long bonefurther includes the step of distracting and aligning said fracturedlong bone.
 11. The surgical method of claim 10, wherein said step ofdistracting and aligning said fractured long bone includes inserting athreaded rod into the distal end of said long bone and manuallydistracting and aligning said fractured long bone.
 12. The surgicalmethod of claim 10, wherein said step of distracting and aligning saidfractured long bone includes inserting an attachment means andattachment clamp to the distal end of said elongated rod and into thedistal end of said long bone and using the attachment means andattachment clamp to manually distract and align said fractured longbone.
 13. The surgical method of claim 9, wherein said step of attachingthe ends of said elongated rod to said fractured long bone furtherincludes the step removing the portion of said attachment means whichextends away from said long bone beyond said attachment clamp to preventsaid attachment means from extending beyond the subcutaneous fat layer.14. A surgical device for minimally invasive fixation of long bonefractures, said device being designed to be placed entirelysubcutaneously including: an elongated rod, said rod being of sufficientlength to extend substantially between the proximal and distal ends ofsaid fractured long bone and being designed to be placed within thesubcutaneous fat layer; a plurality of attachment means designed toattach said elongate rod to said proximal and distal ends of saidfractured long bone; a plurality of attachment clamps, each designed toconnect said attachment means to said elongated rod in a generallyperpendicular fashion.
 15. The surgical device of claim 14, wherein saidattachment clamps include a body having two passageways therethrough,said passageways being generally perpendicular to one another, saidpassageways allowing for passage of said attachment means and saidelongated rod therethrough.
 16. The surgical device of claim 15, whereinsaid attachment clamps further include two set screw passageways thereinto accommodate two set screws which lock said elongated rod and saidattachment means firmly into said attachment clamp.
 17. The surgicaldevice of claim 14, wherein said attachment means is a screw, threadedpin or threaded rod.
 18. The surgical device of claim 14, wherein saidattachment means is a Schanz pin.
 19. The surgical device of claim 14,wherein said attachment means has a shaft portion and said shaft portionis threaded only on the portion thereof that is inserted into said longbone.
 20. The surgical device of claim 14, wherein said attachment meansdoes not extend outward from said long bone beyond said attachmentclamp.